To help ensure patient safety, a Coram clinician may notify a patient and/or their physician of these labeling updates when appropriate.
BLINCYTO (BLINATUMOMAB) The Warnings and Precautions section of the Approved Drug Label (ADL) was updated regarding Neurological Toxicities, including Immune Effector Cell-Associated Neurotoxicity Syndrome. This section now states that patients with Down Syndrome may have a higher risk of seizures with BLINCYTO therapy; consider seizure prophylaxis prior to initiation of BLINCYTO for these patients. The Medication guide was also updated stating these patients may be given anti-seizure medicine before starting BLINCYTO treatment.
OPTISON (ALBUMIN HUMAN) The Adverse Reactions, Clinical Trials Experience section of the Approved Drug Label (ADL) was updated regarding Pediatric Use, stating that the safety profile observed in pediatric patients from clinical study was consistent with the safety profile in adult patients. The Pediatric Use section was updated stating that the safety and effectiveness of OPTISON to opacify the left ventricle and improve the delineation of the left ventricular endocardial borders have been established in pediatric patients with suboptimal echocardiograms. Use of OPTISON in pediatric patients is supported by evidence from adequate and well-controlled studies in adults and additional efficacy and safety data from a clinical study in 37 pediatric patients aged 9 to 17 years old.
TIGECYCLINE (TIGECYCLINE)
VIBRAMYCIN (DOXYCYCLINE)
MINOCIN (MINOCYCLINE HYDROCHLORIDE)
The Warnings and Precautions section of the ADLs were updated to include Dermatologic Reactions. Each of these documents include details for fixed drug eruptions. Fixed drug eruptions have occurred with tetracyclines and medications with similar structure. Worsening severity upon subsequent administrations, including generalized bullous fixed drug eruption, has been observed. If severe skin reactions occur, discontinue the medication immediately and institute appropriate therapy. The Adverse Reactions section for Doxycycline only was further updated to include Psychiatric Reactions of depression, anxiety, suicidal ideation, insomnia, abnormal dreams, and hallucination.
Reference: Drug Safety-related Labeling Changes (SrLC) (fda.gov)
This article contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with Coram.